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Clinical Microbiology Procedures Handbook

12.2.2 Use of Controls and Calibrators

    Last updated:5 Mar 2022
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    ABSTRACT

    Assay controls and calibrators are vital components of any laboratory test (1, 2). Controls allow the laboratory to monitor assay performance on each run…

    REFERENCES

    • 1. CLSI. 2006. Molecular Diagnostic Methods for Infectious Diseases: Approved Guideline. CLSI document MM3‐A2. CLSI, Wayne, PA. Google Scholar
    • 2. CLSI. 2009. Quantitative Molecular Methods for Infectious Diseases: Approved Guideline. CLSI document MM6‐A2. CLSI, Wayne, PA. Google Scholar
    • 3. Sloan LM. 2007. Real‐time PCR in clinical microbiology: verification, validation and contamination control. Clin Microbiol Newsl 29:87–95. Google Scholar
    • 4. Garrett PE. 2001. Quality control for nucleic acid tests: common ground and special issues. J Clin Virol 20:15–21. Google Scholar
    • 5. Valentine‐Thon E. 2002. Quality control in nucleic acid testing—where do we stand? J Clin Virol 25():S13–S21. Google Scholar
    • 6. Mackay IM. 2004. Real‐time PCR in the microbiology laboratory. Clin Microbiol Infect 10:190–212. Google Scholar
    • 7. Röder B, Frühwirth K, Vogl C, Wagner M, Rossmanith P. 2010. Impact of long‐term storage on stability of standard DNA for nucleic acid‐based methods. J Clin Microbiol 48:4260–4262. Google Scholar
    • 8. Saldanha J, Gerlich W, Lelie N, Dawson P, Heermann K, Heath A, WHO Collaborative Study Group. 2001. An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques. Vox Sang 80:63–71. Google Scholar
    • 9. Niesters HGM. 2002. Clinical virology in real time. J Clin Virol 25():S3–S12. Google Scholar
    • 10. Preiksaitis JK, Hayden RT, Tong Y, Pang XL, Fryer JF, Heath AB, Cook L, Petrich AK, Yu B, Caliendo AM. 2016. Are we there yet? Impact of the First International Standard for Cytomegalovirus DNA on the harmonization of results reported on plasma samples. Clin Infect Dis 63:583–589. Google Scholar
    • 11. Hayden RT, Tang L, Su Y, Cook L, Gu Z, Jerome KR, Boonyaratanakornkit J, Sam S, Pounds S, Caliendo AM. 2019. Impact of fragmentation on commutability of Epstein‐Barr virus and cytomegalovirus quantitative standards. J Clin Microbiol 58:e00888‐19. Google Scholar
    • 12. Saldanha J, Lelie N, Heath A, WHO Collaborative Study Group. 1999. Establishment of the first international standard for nucleic acid amplification technology (NAT) assays for HCV RNA. Vox Sang 76:149–158. Google Scholar
    • 13. Baylis SA, Wallace P, McCulloch E, Niesters HGM, Nübling CM. 2019. Standardization of nucleic acid tests: the approach of the World Health Organization. J Clin Microbiol 57:e01056‐18. Google Scholar
    • 14. Madej RM, Davis J, Holden MJ, Kwang S, Labourier E, Schneider GJ. 2010. International standards and reference materials for quantitative molecular infectious disease testing. J Mol Diagn 12:133–143. Google Scholar
    • 15. Hayden RT, Yan X, Wick MT, Rodriguez AB, Xiong X, Ginocchio CC, Mitchell MJ, Caliendo AM, College of American Pathologists Microbiology Resource Committee. 2012. Factors contributing to variability of quantitative viral PCR results in proficiency testing samples: a multivariate analysis. J Clin Microbiol 50:337–345. Google Scholar
    • 16. Peddu V, Bradley BT, Casto AM, Shree R, Colbert BG, Xie H, Santo TK, Huang M‐L, Cheng EY, Konnick E, Salipante SJ, Jerome KR, Lockwood CM, Greninger AL. 2020. High‐resolution profiling of human cytomegalovirus cell‐free DNA in human plasma highlights its exceptionally fragmented nature. Sci Rep 10:3734. Google Scholar
    • 17. Bateman AC, Greninger AL, Atienza EE, Limaye AP, Jerome KR, Cook L. 2017. Quantification of BK virus standards by quantitative real‐time PCR and droplet digital PCR is confounded by multiple virus populations in the WHO BKV International Standard. Clin Chem 63:761–769. Google Scholar
    • 18. Addetia A, Phung Q, Bradley BT, Lin MJ, Zhu H, Xie H, Huang M‐L, Greninger AL. 2021. In vivo generation of BK and JC polyomavirus defective viral genomes in human urine samples associated with higher viral loads. J Virol 95:e00250‐21. Google Scholar
    • 19. Miller WA, Koev G. 2000. Synthesis of subgenomic RNAs by positive‐strand RNA viruses. Virology 273:1–8. Google Scholar